Enforcement record

Voluntary Recall disclosure naming デンカ株式会社

デンカ株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure8 November 2021

Action type

Voluntary Recall

Law

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

Authority

Ministry of Health, Labour and Welfare

Action date

8 November 2021

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Source verification

Public-source and preservation status

Publishing authority: Ministry of Health, Labour and Welfare
Official source URL: Recorded by RegBase
Entity match: Not confirmed; shown under the published name
Kiroku preservation: Completed archive verified; Captured: Jul 12, 2026, 04:21 PM JST

“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.

Open the official source links in the section below to review the original disclosure.

Action summary

Company: デンカ株式会社Japanese only
Original: デンカ株式会社
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
医薬品医療機器等法
Action type: Voluntary Recall
自主回収
Action date: 8 November 2021
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医薬品・医療機器

Violation

Machine-translated summary — verify against original

Regarding the antigen rapid test kits, under the distribution project based on the Ministry of Health, Labour and Welfare's notice titled 'Distribution of antigen rapid test kits to medical institutions, elderly care facilities, etc.' dated June 9, 2021, a total of 1,201,300 units have been distributed out of the 1,300,000 units mentioned above. For the distributed antigen rapid test kits, the Ministry of Health, Labour and Welfare and others have sent distribution destination lists to Denka Corporation, and under Denka's responsibility, including cost burden, the exchange of the new antigen rapid test kits is planned to be carried out.

Show original Japanese text

抗原簡易キットについては、「医療機関・高齢者施設等への抗原簡易キット配布事業について」（令和３年６月９日付厚生労働省新型コロナウイルス感染症対策推進本部事務連絡）に基づく配布事業において、上記1,300,000個のうち1,201,300個が配布されております。配布済みの抗原簡易キットについては、厚生労働省等からデンカ株式会社に対し配布先リストの送付等を行い、費用負担も含めデンカ株式会社の責任の下で新しい抗原簡易キットの交換が行われる予定です。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

This context is an operational aid for review workflows, not a credit opinion or legal conclusion.

Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-25T00:20:41.156+00:00
Evidence checked: 2026-04-25T00:20:41.156+00:00
Archive captured: 2026-07-12T07:21:36.06795+00:00

Show audit JSON

{
  "record": {
    "id": "e30cfd89-3c25-47cb-8453-bfafe7a20778",
    "url": "https://regbase.jp/en/enforcement/other-denka-20211108",
    "company_name_original": "デンカ株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "医薬品医療機器等法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "自主回収",
      "en": "Voluntary Recall"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 85,
    "method": "nta_strict_name_nationally_unique",
    "method_label": "nta_strict_name_nationally_unique",
    "notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (デンカ株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-denka-20211108",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_22115.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/dedeb0cbf3hgrjap",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_22115.html",
    "archiveCapturedAt": "2026-07-12T07:21:36.06795+00:00",
    "extractedAt": "2026-04-25T00:20:41.156+00:00",
    "translatedAt": "2026-05-01T07:09:02.249+00:00",
    "evidenceCheckedAt": "2026-04-25T00:20:41.156+00:00",
    "generatedAt": "2026-09-28T00:57:37.274Z"
  },
  "limitations": [
    "RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
    "English summaries are provided for reference. The original Japanese source is authoritative.",
    "Possible or unresolved entity matches should be manually verified before use in a decision."
  ]
}

The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.

Language

日本語版を見る (Japanese)

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.